Gemäßigte Ganzkörperhyperthermie Bei Patienten Mit Rezidivierten Plattenepithelkarzinomen Der Kopf-Hals Region Nach Hochdosierter Vorbestrahlung: Pilotstudie Zur Beeinflussung Des Tumormikromilieus.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- feasibility of whole body hyperthermia as adjunct to radiochemotherapy
研究概览
简要总结
The aim of the study is to determine the feasibility and efficacy of moderate weekly whole Body hyperthermia Treatment during radiochemotherapy for pre-irradiated locally or regionally recurrent head and neck squamous cell carcinomas.
The Primary aim of the study is feasibility, defined as 80% of patients completing at least four applications of hyperthermia.
Secondary endpoints include an increase of Tumor Perfusion by the use of hyperthermia, measured by magnetic resonance Imaging during week two of Treatment and reduction of Tumor hypoxia, measured by hypoxia specific Positron emission tomography.
详细描述
Previously irradiated patients with loco/ loco-regional recurrent head and neck squamous cell carcinomas usually undergo re-irradiation. However prognosis of these patients is unfavourable, especially for non-human papilloma virus associated cancers. Moderate whole body hyperthermia will be performed by water-filtered IR-A-radiation using a Heckel-HT3000 device.
Preclinical data have indicated that moderate whole body hyperthermia decreases intratumoral interstitial fluid pressure and leads to increased perfusion of the tumor. The study investigates if this holds also true in patients and leads to a marked decrease of tumor hypoxia, measured by 18F-Fluoromisonidazole PET.
The Primary aim of the study is feasibility, defined as 80% of patients completing at least four applications of hyperthermia.
Secondary endpoints include an increase of Tumor Perfusion by the use of hyperthermia, measured by magnetic resonance Imaging during week two of Treatment and reduction of Tumor hypoxia, measured by hypoxia specific Positron emission tomography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with unresectable local, regional or loco-regional recurrent non HPV-associated squamous cell head and neck cancer with prior high-dose radiotherapy of the head and neck region
- •time interval of 6 months to 5 years after completion of last radiotherapy of the head and neck region
- •Completed staging examinations, preferentially 18f-fluorodeoxyglucose (FDG) PET of the whole body
- •general health condition according to ECOG status of 0,1 or 2
- •age between 18 and 75 years
- •written informed consent
排除标准
- •HPV associated primary tumor or recurrent tumor
- •recurrence more than 5 years after end of previous radiotherapy
- •Any medical circumstances impeding the application of radiotherapy, concomitant chemotherapy or whole body hyperthermia
研究组 & 干预措施
Single Arm
Additional application of weekly moderate whole-body hyperthermia concurrent to re-irradiation plus chemotherapy
干预措施: Moderate whole body hyperthermia using water-filtered IR-A-radiation (Device)
结局指标
主要结局
feasibility of whole body hyperthermia as adjunct to radiochemotherapy
时间窗: within 6 weeks of treatment with radiochemotherapy
feasibility is defined as at least 4 cycles of whole body hyperthermia in 80% of patients
次要结局
- Freedom from distant metastases after 2 years of follow-up(3 years (1 year recruitment, 2 years follow-up))
- Reduction of positron emission tomography (PET) measured hypoxia(1 year (recruitment) plus additional 2 weeks (evaluation of PET parameter))
- magnetic resonance imaging (MRI) measured perfusion changes(1 year (recruitment) plus additional 2 weeks (evaluation of MRI parameter))
- Tumor response(1 year (recruitment) and 3 months (follow-up))
- Patient reported quality of life (head and neck cancer specific quality of life)(3 years (i.e. recruitment plus two years of follow-up))
- Local control after 2 years of follow-up(3 years (1 year recruitment, 2 years follow-up))
- Loco-regional control after 2 years of follow-up(3 years (1 year recruitment, 2 years follow-up))
- Overall survival after 2 years of follow-up(3 years (1 year recruitment, 2 years follow-up))
- Patient reported quality of life (general quality of life)(3 years (i.e. recruitment plus two years of follow-up))
研究者
Sebastian Zschaeck
MD, Principal Investigator
Charite University, Berlin, Germany